This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the IBV Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The IBV Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management.

Device: IBV Valve System

Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe.

Other: Medical Management

Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

Active Comparator: Medical Management

The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure.

Other: Medical Management

Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.

Eligibility

Ages Eligible for Study:

40 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject has severe and heterogeneous emphysema with severe dyspnea

Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD

Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m

Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study

Pulmonary Function Testing Results (PFT's) demonstrate:

FEV1 ≤ 45% of predicted

RV ≥ 150% of predicted

TLC ≥ 100% of predicted

Exclusion Criteria:

Patient has a BMI < 15 kg/m2 or > 35 kg/m2

Arterial Blood Gas Level (ABG) indicates:

PCO2 > 50 mm Hg

PO2 < 45 mm Hg on room air

Subject has a diffuse emphysema pattern or α1-antitrypsin deficiency

Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day

Subject has an active asthma (>15 mg of prednisone daily)

Giant bulla (> 1/3 volume of lung)

Pulmonary hypertension

Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812447